Chemical based hazards in pharmaceutical

CHEMICAL BASED HAZARDS
SUBMITTEDTO:
Ms. G.SIVAKAMSUNDARI
ASSISTANT PROFESSOR
DEPARTMENTOF PHARMACY
ANNAMALAI UNIVERSITY.
PRESENTED BY:
P.HARI HARAN
M.PHARM(1ST YEAR)
QUALITY ASSURANCE.

SYLLABUS
 INTRODUCTION
 SOURCES OF CHEMICAL HAZARDS
 HAZARDS OF ORGANIC SYNTHESIS
 SULPHONATING HAZARD
 ORGANIC SOLVENT HAZARD
 CONTROL MEASURES FOR CHEMICAL HAZARDS

INTRODUCTION
 Chemical hazards produce by chemical synthesis or manufacturing,
processing, transportation and that effect on the human and environmental
condition. A chemical hazard is a type of occupational hazard caused by
exposure to chemicals in the workplace.
 There are many types of hazardous chemicals, including neurotoxins,
immune agents, dermatologic agents, carcinogens, reproductive toxins,
systemic toxins, asthma genes, pneumoconiotic agents, and sensitizers.

INTRODUCTION…
 Exposure to chemicals in the workplace can cause acute or long-term
detrimental health effects.
 The frequency and severity of chemical hazards have increased in recent
years due to the rapid development of the largest chemical industries -
production and formulation, petrochemicals, pharmaceuticals,
agrochemicals, industrial chemicals, and hazardous chemicals - oil deposits,
exploration/extraction and reclamation sites, and so on.

INTRODUCTION…
 Pharmaceutical industries have many environmental problems, like the
other chemical industries, especially in API manufacture.
 Major chemical (industrial) hazards are low in frequency but are significant
in terms of potential loss of lives, injuries, environmental impacts, property
damage, and socioeconomic implications.
 Increasing the size of plants, deposits, and bearers, especially in densely
populated areas, represented the greatest risk and vulnerability to these
dangers.

REGULATORY AGENCIES
GLOBAL:
 United States Food and Drug Administration(USFDA).
 World Health Organization (WHO).
 International Conference on Harmonization(ICH).
 National Administration of Drugs, Food, and Medical Technology(ANMAT).
INDIAN:
 Drugs and cosmetics act, 1940.
 Insecticides act, 1968.
 Hazardous waste (management and handling) rules, 1989.
 Narcotic drugs and psychotropic substances act 1985.

PICTOGRAMS USED IN CHEMICAL HAZARDS
EXPLOSIVE(E) OXIDISING(O) HIGHLY FLAMMABLE& EXTREMELY FLAMMABLE(F,F+)

PICTOGRAMS USED IN CHEMICAL HAZARDS…
TOXIC ORVERY TOXIC(T,T+) (Xn,Xi) HARMFUL&IRRITANT (B)

PICTOGRAMS USED IN CHEMICAL HAZARDS…
BIOHAZARDS(B) DANGEROUS FOR ENVIRONMENT(N) RADIOACTIVE(R)

SOURCES OF CHEMICAL HAZARDS
 The production and use of chemicals are fundamental factors in the
economic development of all countries, whether they are industrialized or
developing.
 In one way or another, chemicals affect directly or indirectly to all humans
and are essentials to our feeding (fertilizers, pesticides, food additives,
packing), our health care (pharmaceuticals, cleaning materials), or our well-
being (appliances, fuels).

SOURCES OF CHEMICAL HAZARDS…
 Chemical hazards are toxic, corrosive, irritant, carcinogenic, flammable, and
mutagenic. According to workplace hazardous materials information,
chemical hazards are classified as:
Class A:
a) Compressed gas.
b) Dissolved gas or liquefied gas.

Class B:
a) Flammable gases.
b) Flammable and combustible liquids.
c) Flammable solid.
d) Flammable aerosols.
e) Reactive flammable material.

Class C:
a) Oxidizing materials - oxidizer and organic peroxide.
b) Oxidizer: Chlorates, nitric oxide, peroxides, permanganates, perchlorates,
nitrites, nitrates, and easily oxidize metal powder.
c) Organic peroxide:Tetra hydro furan, diethyl ether, dioxane, and methyl
isobutyl ether.

Class D:
Poisonous and infectious materials.
e.g.: Cyanides, tea salts, and asbestos.
Class E:
Corrosive materials.
e.g.: Inorganic acids and bases, hydrogen fluoride.

Class F:
a) Dangerous reactive materials.
e.g.: Ethylene dioxide, organic azides, Na, Li, Ca.
b) Pyrophosphoric materials.
e.g.:White phosphorous, diethyl aluminum chloride, and lithium.

Air born toxics:
 Irritants,
 Ipecac, podophyllum, etc.
 Asphyxiants,
 Carbon dioxide, monoxide, methane, ethane, and hydrogen cyanide,
 Hydrogen sulfide, helium, nitrogen, etc.,

 Narcotics/anesthetics,
 Acetone, ether, chloroform, methyl ethyl ketone, etc.
Carcinogens:
 Coal tar, creosote oil, anthracene oil, paraffin oils, and chromium,
 Nickel, cobalt, etc.,
 Hazards may arise when impure or contaminated chemicals are used.

Source of hazards in pharma:
 Handling and storage of huge quantity hazardous chemicals.
 Transferring, loading and unloading of solvents and chemicals to reaction
vessels.
 Emission of hazardous air pollutants from reaction vessels due to
overloading or under designed reaction vessels.

 Human errors while handling hazardous chemicals.
 Volatile organic compounds (VOCs) releases from uncontained (or not
connected to scrubbers).
 Reaction vessels and most commonVOCs include methanol,
dichloromethane, toluene, ethylene glycol, N, ndimethylformamide, and
acetonitrile.
 Leaks of effluents from wastewater treatment plants or from effluent
collection sumps from process area.

HAZARDS OF ORGANIC SYNTHESIS
Organic chemical synthesis presents industrial hazards of three main types:
 First, the active agents used to attack and modify the structure of organic
compounds are, by their very nature, exceptionally able to attack and
modify the organic compounds of the human body, thus producing highly
poisonous effects.
 Second, the intermediate compounds in most organic syntheses are often
characterized by the readiness with which they enter into chemical
combination with other organic matter; they are active.

HAZARDS OF ORGANIC SYNTHESIS…
 Third, the final products, though they are medicines designed to be introduced into
the human body, may nevertheless produce severe poisoning under conditions of
industrial exposure.
Common hazards of organic synthesis with examples, causes, and management:
S.
No.
Hazard causing
agents
Examples Hazards caused Hazards management
1 Chlorinating agents
Chlorine, phosgene (COCl2)
(gases), Phosphorus
oxychloride (POCl5),
thionyl chloride (SOCl2)
[liquids],Phosphorus
pentachloride (PCl5) [solid].
Lung irritants; may
produce pulmonary
edema if inhaled in
sufficient amounts.In
addition to being
poisons, they are highly
corrosive to common
metals.
The workers should
be equipped with air-
supply masks or
closed oxygen
systems.

2 Sulfonating Agents
Chlorosulfonic acid
(HOSO2Cl) (used in the
manufacture of
p-acetylaminobenzene
sulfonyl chloride, a
necessary intermediate
for most sulfonamides).
Conc. H2SO4 and fuming
sulfuric acid (oleum).
The fumes of the acid are
highly irritating.
In many sulfonation reactions,
HCL gas and SO2 are given off
which may lead to bronchitis
and conjunctivitis.
The heat of reaction of oleum
and water is so great that it
requires proper method for
washing this acid off the skin,
if spilled.
Scrubbing towers of
simple and cheap design,
or very high stacks, are
usually required to
eliminate the nuisance.
Liberal dousing with
anhydrous ethyl alcohol
for first wash, followed
immediately by streams
of water.

3 Methylating agents
Dimethyl sulfate
[(CH3)2SO4].
Diazomethane.
It is a highly corrosive, volatile liquid
with vesicant and lung-irritant
properties.
It is an extremely poisonous, yellow,
odorless gas. Results in red, itching areas
and blisters on the skin. Inhalation causes
severe bronchial catarrh and disturbance
of eye accommodation.
It must be handled
with the care.
Closed system,
ventilation,
explosion-proof
electrical equipment
and lighting. Use
protective gloves and
clothing.

4 Acetylating Agents
Glacial acetic acid, acetic
anhydride, monochloroacetic
acid, and dichloroacetic
acids.
Results in extensive
desquamation of the skin,
especially on the palms and
are also categorized as lung
irritants.
If spilled, soak the
affected parts for 4 h
in NaHCO3 solution
to prevent the
damage as it permit
the reagent to diffuse
out of the skin.
5 Condensing Agents
Sodium methylate and
sodium ethylate.
Conc. sulfuric acid is also
used.
Have corrosive effect on
tissues.
Use closed system or
ventilation, protective
gloves and clothing.
Wear safety
goggles or eye
protection.

SULPHONATING HAZARD
Ethyl methanesulfonate is a colorless liquid. It is used in biochemical research
and as an experimental mutagen.It can affect you when breathed in.It should
be handled as a carcinogen and a teratogen with extreme caution.
Acute Health Effects
short term:
 Contact can irritate the skin and eyes.
 Breathing ethyl methanesulfonate can irritate the nose and throat.

SULPHONATING HAZARD…
 High or repeated exposure to ethyl methanesulfonate may cause nausea,
vomiting and drowsiness..
Long term:
 It may be a carcinogen in humans since it has been shown to cause lung and
kidney cancers in animals.
 It may damage the developing fetus and the testes (male reproductive
glands).
 It has not been tested for other chronic health effects.
•

MedicalTesting:
There is no special test for this chemical. However, if illness occurs or
overexposure is suspected, medical attention is recommended.
WORKPLACE EXPOSURE LIMITS:
No occupational exposure limits have been established for Ethyl
Methanesulfonate.This does not mean that this substance is not harmful. Safe
work practices should always be followed. so all contact should be reduced to
the lowest possible level.

WORKPLACE CONTROLS AND PRACTICES:
 Unless a less toxic chemical can be substituted for a hazardous substance,
engineering controls are the most effective way of reducing exposure.
 The best protection is to enclose operations and/or provide local exhaust
ventilation at the site of chemical release. Good work practices can help to
reduce hazardous exposures.

The following work practices are recommended:
 Workers whose clothing has been contaminated by ethyl methanesulfonate
should change into clean clothing promptly.
 Contaminated work clothes should be laundered by individuals who have
been informed of the hazards of exposure to ethyl methanesulfonate.
 Eye wash fountains should be provided in the immediate work area for
emergency use.

 If there is the possibility of skin exposure, emergency shower facilities
should be provided.
 On skin contact with ethyl methanesulfonate, immediately wash or shower
to remove the chemical. At the end of the workshift, wash any areas of the
body that may have contacted, whether or not known skin contact has
occurred.
 Do not eat, smoke, or drink where ethyl methanesulfonate is handled,
processed, or stored, since the chemical can be swallowed. Wash hands
carefully before eating, drinking, smoking, or using the toilet.

PERSONAL PROTECTIVE EQUIPMENT:
 Clothing.
 Eye Protection.
 Respiratory Protection.
Work place controls are better than personal protective equipment. However,
for some jobs (such as outside work, confined space entry, jobs done only once in a
while, or jobs done while workplace controls are being installed), personal
protective equipment may be appropriate.

ORGANIC SOLVENT HAZARD
 A large number of organic compounds, namely, alcohols (e.g. methanol,
ethanol)ketones(e.g. acetone)aromatic compounds(e.g. benzene,
toluene)nitrates and halogenated hydrocarbons and manyothers are
widely used as solvents in both laboratories and chemical industries.
 Organic solvents are used in chemical laboratories for synthesis, extraction,
separation, purification and drying, analytical methods, spectrometric and
physicochemical measurements.

ORGANIC SOLVENT HAZARD…
 In chemical industries, they are widely used to dissolve and disperse fats,
oils, waxes, pigments, paints, rubber, and so on.
 They are also used as antifreeze, degreasing, and cleaning agents; as
volatile organic liquids that easily evaporate at normal temperature and
pressure, produce volatile organic compound emissions.
 For example, trichloroethylene is most commonly used as a degreasing
agent for metal parts in the industry and its use at work is linked to an
increased risk of developing Parkinson’s disease six times.

Characteristics of organic solvents that determine the type of danger:
 Spills and solvent leakage cause significant air, soil, and water pollution.
 Inhalational exposure of volatile organic solvents and an easy absorption
through the skin are the two most important ways of exposure to the
workplace.

 For example, solvents such as dimethyl sulfoxide and glycol ethers, which
have water and lipid solubility, are well absorbed through the skin.
 Many organic solvents have low flammability points and burn when they
light up.
 The flammability and explosiveness of a solvent are decisive determinants
of the risk associated with its use, for example, nitrocellulose.

Classification is used to qualify the flammability hazard associated with a
solvent:
• Highly flammable: Flashpoint 23°C.
• Flammable: Flammability point 23–61°C.
• Combustible: Flammability point 61–150°C [11].
Classification of solvents on the basis of carcinogenicity by the international
agency for research on cancer:

Group Description
Group 1
carcinogenic to humans, which are based mainly on studies in humans, e.g.: Benzene
(recognized human carcinogen) as it is associated with certain forms of Leukemia in
heavily exposed workers
Group 2A
Probably carcinogenic to humans, based on sufficient evidence from animal studies, e.g.:
Tetrachloroethylene, TCE, acrylamide, benzidine-based dyes, diethyl sulfate,
and formaldehyde
Group 2B
Possibly carcinogenic to humans, based on a combination of effects in humans, animals
and other evidence. e.g.: Dichloromethane, ethyl acrylate,
tetrachloroethylene, chloroform, acetaldehyde, styrene
Group 3 Not classifiable as to its carcinogenicity to humans due
to limitations in the dataset
Group 4
Probably not carcinogenic to humans, based on a combination of effects in
epidemiologic and animal
studies together with other evidence
TCE:Trichloroethylene

CONTROL MEASURES
Technical measures that can be used to prevent chemical dangers at the
source and/or reduce staff exposure are:
a. Elimination.
b. Substitution.
c. Isolation.
d.Ventilation system.
e. Personal protective equipment.
f. Engineering control.
g. Administration control.

CONTROL MEASURES…
Elimination :
 The most effective and reliable controls are those that result in the
elimination of the hazardous chemical.
Substitution:
 Substitution of a hazardous chemical for a less hazardous one is the next
control of choice; however, care must be taken to ensure that the
substituted chemical does not introduce new hazards.
 Substitution also may involve using the chemical in a less hazardous form or
process (e.g., use of the chemical in a pellet form rather than a dust).

CONTROL MEASURES…
Isolation:
 Isolation of the chemical in time or space from those potentially exposed
can be an effective means of control (e.g., locating people in a protected
control room, installing a buffer area around a chemical reactor, using the
material when people are not in the vicinity).
Ventilation:
Local ventilation:
 If it is not possible to isolate experimental activities involving hazardous
materials, then a properly designed local ventilation solution should be
found, which generally helps remove contaminants at the source.

CONTROL MEASURES…
 A ventilation system consists of a hood, duct or pipe drain, a collecting
system and contaminants are separated from clean and efficient air to
create the fan suction force required.
 However, hazardous gases, fumes, and dusts from the ventilated air
collection must be handled or treated before disposal. Inspection, proper
maintenance, regular cleaning, and changing filters are essential for the
protection against hazardous pollutants.

CONTROL MEASURES…
General ventilation:
 When it is difficult or impossible to avoid hazardous chemicals, fumes,
dusts, fogs, or particles entering the laboratory air at the source, general
dilution ventilation can be installed so that the maximum concentration of
pollutants in the air does not exceed theTLV(threshold limit values),of the
substance.
 At the best, it should consist of a clean air supply and a forced exhaust
outlet in the right place. It can also be used in conjunction with other
preventative measures.

CONTROL MEASURES…
Personal protective equipment:
 Any residual risk may require workers to wear PPE to reduce exposure to
chemicals absorbed through respiration or skin or eye contact.
 Specialist knowledge may be required to ensure selection of the correct
type of PPE for a specific chemical.
 Inappropriate or poorly maintained PPE itself can act as a source of
chemical exposure (e.g. contaminated gloves can be a source of ongoing
exposure through persistent permeation or occlusion of the chemical inside
the gloves).

CONTROL MEASURES…
 Selection of gloves for protection against chemicals absorbed through the
skin requires reference to chemical resistance charts or databases and
consideration of the potential for chemical permeation, penetration, and
degradation of the PPE. In some situations, chemically resistant safety .
 While it would be expected that the risk associated with tasks such as
decanting of chemicals would be controlled through the enclosure or other
engineering controls.

CONTROL MEASURES…
 some chemical handling tasks may require eye protection. Depending on
the task, this may be safety goggles or full face protection.
Engineering controls:
 Engineering controls typically reduce exposure at the source (e.g., by
enclosing the process in vessels or pipes, or by local exhaust ventilation).
 Prevention of uncontrolled releases is important; this may be achieved
using strategies such as quantity reduction and segregation.

CONTROL MEASURES…
Administrative controls:
 In general, administrative controls will be required to supplement higher-
level controls.
 Administrative controls may include maintenance of equipment and
training of workers and their managers in the operation of the equipment.
Preventative maintenance is important in preventing uncontrolled releases.
 Work procedures may need to be developed to ensure that engineering
controls function as designed; this includes any safe-handling procedures
and special storage instructions.

REFERENCE
1. “Chemical hazards in pharmaceutical industry: an overview” by Princy
agarwal,anju goyal,rajat vaishnav ; asian journal of pharmaceutical and
clinical research;2017.
2. Chemical hazards and safety management in pharmaceutical industry by
O.G.Bhusnure,R.B.Dongare,S.B.Gholve,P.S.Giram; research gate;2018.
3. www.OSHA.gov ,occupational Safety and health administration(OSHA).
4. Hazardous substance fact sheet;new jersey;2000.

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